General Manager, Fill Finish

Biogen

Baar, Switzerland

You will oversee technical and business operations at designated external manufacturing sites, serving as the primary point of accountability for strategic and tactical activities and be responsible for driving strategic initiatives for business growth and operational excellence. Responsible for up to 5 CDMO sites and up to $100m in spend, they will ensure supplier performance meets quality, cost, and delivery specifications, and be responsible for establishing and adhering to external manufacturing budget for designated sites. This role includes driving continuous improvements in efficiency, quality, and cost-effectiveness across manufacturing processes. You will establish and maintain strong partnerships with external partners to foster effective collaboration and long-term success. Leading cross-functional teams, they will address complex manufacturing issues and ensure compliance with regulatory requirements. You will be responsible for CDMO site selection, contract negotiation, and aligning manufacturing strategies with internal stakeholders. Your leadership will also involve liaising with governmental agencies as needed to uphold operational standards. Collaboration with the cross-functional stakeholders will be key in facilitating technology transfers and validations. You will lead a small team of direct reports.

What you'll do

Advocate for and represent a team of External Site Leads in global leadership teams and present high-level project risks, milestones, and stage gates to senior leadership. Collaborate globally with directors and managers of other line functions to ensure delivery of process transfers to the timelines required by the Asset Development Program Management Teams;
Identify, define, and lead optimization projects resulting in improved (simplified, more robust, or clearer) business processes for external manufacturing technical operations. Directs the implementation of the agreed-upon solutions and is accountable for the effectiveness of new process(es). Cultivate continuous improvement environment within tech transfer teams at both internal and external sites;
Understand and respond to global supplier cluster business priorities and translate these into tactical objectives. Ensures technical alignment of all functions within external manufacturing and PO&T for responsible Supplier cluster;
Manage budget, staffing, and performance management duties for the team. Provide technical direction, leadership, and development to people leaders and individual contributors;
Ensure compliance of external technical operations within with both Biogen procedures and cGXP regulations and guidelines. Ensure that all external manufacturing protocols and reports are compliant with both agency expectations for their respective locations and modalities;
Revenue Impact and Spend Oversight

Who you are

Experience with supplier relationship management. Demonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams. Strong negotiation skills. Strong technical proficiency within fill and finish development and manufacturing is a must. Experience across modalities required.

Qualifications

Education: Masters or Ph.D. in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or closely allied discipline;
Minimum 12 years of experience in biotech/pharmaceutical cGMP manufacturing industry;
Experience with supplier relationship management;
Demonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams;
Strong negotiation skills demonstrated in prior roles;
Strong technical proficiency within fill and finish development and manufacturing is a must;
Experience across modalities required.

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